FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
Report
- Report Number
- 1530449-2010-00041
- Event Type
- Other
- Date Received
- April 5, 2010
- Report Date
- November 2, 2009
- Manufacturer
- PROCTER & GAMBLE MANUFACTURING CO.
- Product Code
- KOO
- PMA / PMN Number
- K945200
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
LOT NUMBER OR PRODUCT WAS NOT PROVIDED THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. (US) OTC DEVICE: YES.
PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER], NEUROPATHY [NEUROPATHY PERIPHERAL], SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY], EXCESS ZINC [BLOOD ZINC INCREASED], COPPER DEPLETION [BLOOD COPPER DECREASED], ZINC POISONING [METAL POISONING], PAIN [PAIN]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM AND SUPER POLIGRIP DENTURE ADHESIVE CREAM ON HER DENTURES AND REPORTED THE FOLLOWING: DIAGNOSED WITH NEUROPATHY IN 2007, DIAGNOSED WITH EXCESS ZINC AND RESULTING COPPER DEPLETION IN THE PAST YEAR, ZINC POISONING, PAIN, PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, AND SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU | NONE | KOO | PROCTER & GAMBLE MANUFACTURING CO. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Disability |